JP7443528B2 - Body lumen positioning device - Google Patents

Description

This disclosure generally relates to medical devices, systems, and methods for positioning devices and/or anatomical structures during medical procedures. More specifically, in some embodiments, the present disclosure relates to medical device and/or anatomical structure positioning devices, access devices, and systems and methods thereof for use during gastrojejunostomy procedures. .

Various health problems, such as obesity and diabetes, can affect the growing population, cause additional diseases, and increase risks to patients' health. Surgical procedures such as bariatric surgery, e.g., restricting part of the stomach and/or bypassing part of the intestine and/or other parts of the gastrointestinal (GI) tract, may interfere with these and/or other may be an option for certain patients with health problems. These types of procedures can have serious side effects, such as changes in intestinal hormones, associated complications, tissue trauma, anastomotic leaks, infections, and/or alterations to the initial surgery. additional surgery, such as changing the placement of a bypass device, may result in an invasive surgical procedure with potentially increased risks to the patient.

Therefore, less invasive medical devices, systems, and related methods for treating the gastrointestinal tract and/or bypassing portions of the intestine are needed to address some of these and other health problems. may be desirable to reduce complications associated with the treatment of This disclosure may solve one or more of these problems or other problems in the art.

According to one aspect, a medical device locator may include an elongated member that includes a positioning device at a distal end thereof. The positioning device may include at least one light emitting diode (LED), and the at least one LED may be configured to operate to emit light having wavelengths corresponding to green light and red light.

The positioning device may include a sidewall, a proximal endwall at a proximal end of the sidewall, and a distal endwall at a distal end of the sidewall, the sidewall, proximal endwall, and distal endwall forming a cavity. may be defined, and at least one LED may be disposed within the cavity.

The sidewalls may include transparent or translucent materials, and at least one of the proximal or distal endwalls may include one or more of opaque or light attenuating materials.

The elongate member may include a fluid lumen extending from a proximal end of the elongate member to a distal end of the elongate member. A plurality of holes may be disposed in the sidewall of the elongate member and fluidly connected to the fluid lumen.
A vacuum device and a fluid containment device may be connected to the elongate member, and each of the vacuum device and fluid containment device may be in fluid communication with the fluid lumen at a proximal end of the elongate member, and the vacuum device may The suction may be configured to create a suction within the fluid lumen such that fluid may be configured to flow through the plurality of holes and along the fluid lumen to the fluid containing device.

The elongate member may include a central lumen configured to receive a guidewire.
The positioning device may include a balloon at the distal end of the elongate member, and the balloon may be configured to be inflated.

The balloon may include a transparent or translucent material, and the at least one LED may be disposed on the surface of the elongate member, and the light emitted from the LED may be configured to pass through the balloon. .

The balloon may be disposed on a first side of the elongate member, and the at least one LED may be disposed on a circumferentially opposite side of the elongate member from the balloon.
The at least one LED may include multiple LEDs. Multiple LEDs may be placed around the balloon.

The elongate member may include an elongate member body and an elongate member distal tip, and the proximal end of the elongate member distal tip may be connected to the distal end of the elongate member body by a plurality of wires. , one LED of the at least one LED may be attached to each wire from the plurality of wires.

An actuation wire may be attached to the distal tip of the elongate member, the actuation wire may be configured to move proximally relative to the body of the elongate member, and the LED may be configured such that the actuation wire is attached to the distal tip of the elongate member. The distal end may be configured to be moved radially outward as the distal end is moved proximally relative to the body of the elongate member.

The at least one LED may be configured to alternately emit green and red light.
The at least one LED may be configured to emit green and red light in a pulsed manner.

A system with a medical device locator may include an endoscope having an imaging device and an end effector extending from a distal end of the endoscope, the imaging device including a green color emitted from the at least one LED. The locator may be configured to detect light from the locator having a wavelength corresponding to light and red light.

According to another aspect, the method includes inserting an endoscope into the body and advancing the endoscope into the body's stomach, the distal end of the endoscope including a camera; inserting the elongate member into the body, the distal end of the elongate member including at least one light emitting diode (LED); and advancing the elongate member through the stomach and into the small intestine of the body. activating the at least one LED to emit a first light having a first wavelength; detecting the first light using a camera; and activating the at least one LED to emit a first light having a first wavelength. The method may include emitting a second light having a second wavelength different from the wavelength, and detecting the second light using a camera.

The method may further include creating one or more incisions in the stomach wall and the small intestine wall corresponding to the location of the at least one LED.
The first light may have a wavelength that corresponds to red light, and the second light may have a wavelength that corresponds to green light.

According to yet another aspect, the method includes inserting an endoscope into the body and advancing the endoscope into the body's stomach, the distal end of the endoscope including a camera. inserting the elongate member into the body, the distal end of the elongate member including a positioning device including at least one light emitting diode (LED); and advancing the elongate member through the stomach and into the small intestine of the body. creating an incision in the stomach wall; advancing an endoscope through the incision in the stomach wall; activating at least one LED to a red light; and emitting the red light using a camera. activating at least one LED to emit green light; detecting the green light using a camera; creating an incision in the wall of the small intestine; detecting the red light and emitting the green light; and positioning the stent to connect the wall of the stomach and the wall of the small intestine based on at least one of the detection of the light. The at least one LED may be activated to emit red and green light in a pulsed manner.

In another aspect, a medical device locator may include an elongate member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. The positioning device may be positioned along the length of the elongate member.

In various embodiments described herein and otherwise within the scope of this disclosure, the elongate member may be a tubular sheath extendable around the catheter. A plurality of lighting members may be arranged along the length of the elongate member. The positioning device may include an expandable member disposed along a distal end of the elongate member. An inflation lumen may extend along the length of the elongate member in fluid communication with the expandable member. The plurality of lighting members may include LEDs disposed along the length of the elongated member, the LEDs being operable to emit light having a wavelength corresponding to green light or red light. The positioning device may include one or more LEDs of a plurality of illumination members at a distal point of the illumination member along the discernable elongated member for positioning the medical device. The positioning device may include one or more LEDs of a plurality of lighting members connected to the distal end point. A plurality of leads may be in electrical communication with a plurality of lighting members extending along the elongate member. A controller may be in electrical communication with a plurality of leads extending along the elongate member. The controller may be configured to selectively activate a portion of the plurality of lighting members in a distal direction along the length of the elongate member. The controller may be configured to sequentially activate the selected one or more LEDs of the plurality of lighting members in a distal direction along the length of the elongate member. The controller may be configured to actuate all of the lighting members of the plurality of lighting members except one of the lighting members, the one lighting member being in the distal direction. It is sequentially changed upon activation of each of the lighting members. The plurality of illumination members include selected illumination members along a proximal portion of the elongated member having a first wavelength and selected illumination members along a distal portion of the elongated member having a second wavelength; May include. The plurality of illumination members may be operable at decreasing frequency intervals distally along the length of the elongated member. The plurality of illumination members are arranged along the length of the elongate member such that the density of the illumination members increases along the length of the elongate member extending along the elongate member from a proximal end toward a distal point. may be placed. The plurality of lighting elements may be individually selectable and controllable as a single lighting element or as a group of multiple lighting elements. The plurality of lighting members may extend for a distance of about 50 centimeters along the length of the elongated member.

In another aspect, a system for positioning a medical device may include a medical device locator including an elongate member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. . The positioning device may be positioned along the length of the elongate member. A plurality of lighting members may be arranged along the length of the elongate member. The elongate member may be extendable within the first body lumen. The medical device may be positionable within the second body lumen. The medical device is positionable using a medical device locator at a target location in a second body lumen opposite a positioning device across a tissue wall of the first body lumen and a second tissue wall of the body lumen. It may be. The plurality of lighting members may include LEDs. A controller may be electrically coupled to the plurality of LEDs. The controller may be configured to selectively activate the plurality of LEDs in a distal direction along the length of the elongated member.

In another aspect, a method of positioning a medical device locator may include inserting an elongated member within a first body lumen. The elongate member may include a plurality of LEDs extending along the length of the elongate member. A positioning device may be located at the distal end of the elongated member. The controller may be configured to selectively activate the plurality of LEDs in a distal direction along the length of the elongated member. The activated plurality of LEDs may be visible across a wall of the first body lumen to position the locating device at a target location within the first body lumen. The opening may be cut across the wall of the second body lumen toward the first body lumen at the target location, and the opening may be cut across the wall of the first body lumen at the target location. may be done. The positioning device may include one or more of the plurality of LEDs. Visualization of the activated LEDs may be performed from within the abdominal cavity.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

The human gastrointestinal system is shown. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 1 illustrates an example embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. 2A-2F is a perspective view of an example catheter and positioning device for use with the system of FIGS. 2A-2F, according to one aspect of the present disclosure; FIG. 2A-2F are perspective views of example catheters and positioning devices for use with the systems of FIGS. 2A-2F, according to one aspect of the present disclosure; FIG. 2A-2F is a perspective view of an example catheter and positioning device for use with the system of FIGS. 2A-2F, according to one aspect of the present disclosure; FIG. 2A-2F is a perspective view of an example catheter and positioning device for use with the system of FIGS. 2A-2F, according to one aspect of the present disclosure; FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to an aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to an aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to an aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to an aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to an aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one aspect of the present disclosure. FIG. 2A-2F is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one aspect of the present disclosure. FIG. 2 illustrates an elongate member extending into the jejunum and an instrument extending through the wall of the stomach and into the abdominal cavity towards the elongate member, according to one aspect of the present disclosure. 11B shows the system of FIG. 11A with instruments for manipulating the jejunum. 11A and 11B are shown with an instrument extending through the wall of the jejunum. 2 illustrates an elongate member having a plurality of LEDs arranged along its length, according to one aspect of the present disclosure. 2 illustrates an elongated member having a plurality of LEDs arranged along its length, according to one aspect of the present disclosure. 2 illustrates an elongate member having a plurality of LEDs arranged along its length, according to one aspect of the present disclosure.

The present disclosure is described with reference to an exemplary medical system that may be used in endoscopic medical procedures. Note, however, that reference to this particular treatment is provided for convenience only and is not intended to limit the disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed devices and associated methods of use may be utilized in any suitable treatment, medical or otherwise. The present disclosure can be understood with reference to the following description and accompanying drawings, in which like elements are referred to with the same reference numerals.

Wherever possible, the same or similar reference numbers will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part furthest from the user when the device is introduced into the patient. In contrast, the term "proximal" refers to the part closest to the user when placing the device on the patient. As used herein, the term "comprises," or any other variations thereof, means that a process, method, article, or apparatus that includes a list of elements does not necessarily include only those elements. Covering non-exclusive inclusion such that it need not include and may include other elements not expressly listed or other elements specific to such process, method, article, or apparatus. is intended. The term "exemplary" is used to mean "example" rather than "ideal." Additionally, as used herein, the terms "about," "approximately," and "substantially" mean +/-10% of the stated or implied value. Indicates a range of values within. Additionally, terms referring to component/surface geometry refer to exact shapes and approximate shapes.

Embodiments of the present disclosure provide medical device locators for positioning medical devices within specific portions of the gastrointestinal tract for specific purposes (e.g., to affect metabolism and affect weight loss). , systems and methods, such embodiments include, for example, anal access to the transverse colon, ascending colon, or ileum, the Roux-en-Y procedure, the jejunocolic bypass, the jejunal Ileal bypass, gastrectomy, biliopancreatic diversion with duodenal switch (BPD-DS), gastrojejunostomy, segmental colectomy, and by visualizing the beacon from outside the lumen, the instrument can For a variety of different purposes, including other procedures, including using a medical device locator with a beacon to position a target portion of a body lumen to allow access to the cavity; It should be appreciated that various configurations of such medical devices may be used to place in a variety of different body lumens and/or passageways.

Although the present disclosure includes a description of anastomoses, openings, or fistulas formed in the gastrointestinal tract to affect weight and absorption, the devices, systems, and methods herein are applicable to various other portions of the gastrointestinal tract. It may also be performed for various other drainage and/or conduit purposes along or between lumens outside the gastrointestinal tract.

References herein to "an embodiment," "some embodiments," "other embodiments," etc. refer to specific features of the described embodiment. , structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in connection with one embodiment, it is also described in connection with other embodiments unless explicitly stated to the contrary, whether explicitly or not. It would be within the knowledge of those skilled in the art to influence such features, structures, or properties. That is, the various individual elements described below, even if not expressly shown in any particular combination, may be used to form other additional embodiments or as described, as will be understood by those skilled in the art. It is contemplated that they can be combined or arranged with each other to complement and/or enrich the embodiments described.

Referring to FIG. 1, a gastrointestinal system 100 is shown. Gastrointestinal system 100 may include a stomach 105, a small intestine 125, and a pylorus 110 that connects stomach 105 to small intestine 125. Small intestine 125 includes duodenum 115 and jejunum 120, with duodenum 115 being proximal to jejunum 120, and the junction of duodenum 115 and jejunum 120 being defined by the location of the ligaments of trites 130 that connect to small intestine 125. As described herein, an anastomosis can be created between stomach 105 and jejunum 120 to bypass portions of pylorus 110, duodenum 115, and/or jejunum 120. In this way, gastric contents (e.g., food, fluids, and nutrients) are not absorbed or have limited absorption, and/or gastric contents (e.g., food, fluids, and nutrients) are absorbed as they move from the stomach 105 through the small intestine 125. absorption may be delayed, which can promote weight loss in patients and, in some instances, improve weight-related or other health conditions, such as resolution of type 2 diabetes. be exposed.

2A-2F, an example of an endoscopic procedure, such as a gastrojejunostomy, according to the present disclosure is shown. In a first step 200, a nasal catheter 230 may be inserted into the patient, eg, through the nose and esophagus, and into the patient's stomach 105 and/or small intestine 125. Distal end 235 of nasal catheter 230 may be positioned within small intestine 125 at a desired distance to jejunum 120, as determined by a medical professional and/or based on a medical procedure. Nasal catheter 230 may be advanced by a medical professional by peristalsis and/or by pushing a handle associated with the proximal end of nasal catheter 230, thereby moving nasal catheter 230 distally. I can do it. As described herein, nasal catheter 230 may be configured to slide over a guidewire such that nasal catheter 230 is placed within gastrointestinal system 100. As shown in FIG. 2B, in a second step 205, an endoscope 240 may be inserted into the stomach 105 such that the distal end 245 of the endoscope 240 is connected to a nasal catheter located in the jejunum 120. 230 is placed in a region of the stomach 105 that is near the distal end 235 of the stomach 105, such as the fundus of the stomach that has a greater curvature, and/or the antral portion of the stomach.

Once the distal end 245 of the endoscope 240 is in place within the stomach 105, a perforation or other incision is made in the inner wall of the stomach 105 at step 210, as shown in FIG. 2C. A grasping mechanism, such as an end effector 250 at or extending from the distal end 245 of the endoscope 240, and the distal end 245 of the endoscope 240 may be used to grasp the stomach 105 after an incision is made in the wall of the stomach. being pushed outward. The position of distal end 245 relative to stomach 105 is determined by a medical professional by placing a positioning device on distal end 235 of nasal catheter 230, as described in detail herein. Once the outer wall of the jejunum 120 is grasped by the grasping member, an incision or other opening can be created in the jejunum 120, as described herein.

In step 215, shown in FIG. 2D, piercing mechanism 250 may be penetrated into jejunum 120 while maintaining the position of nasal catheter 230 within jejunum 120, such as via fixed guidewire 255. It will be appreciated that the location of the distal end 235 of the nasal catheter 230, and thus the location of the incision in the small intestine 125, may depend on the patient and/or medical procedure. As shown in FIG. 2E, an anastomotic stent 260 is deployed from the endoscope 240 in step 220 to join the opening created in the wall of the stomach 105 and the opening created in the wall of the jejunum 120; Thereby creating a bypass between the pylorus 110 and the duodenum 115, for example a gastrojejunostomy.

In FIG. 2F, a pylorus occlusion device 265 can be placed in the pylorus to prevent the patient's stomach contents from moving through the pylorus 110 and being diverted through the anastomotic stent 260. Pylorus occlusion device 265 may be any configuration for preventing food, fluid, and/or nutrients from flowing from stomach 105 to duodenum 115. Rather, gastric contents may flow directly from stomach 105 to jejunum 120 via anastomotic stent 260, thereby limiting and/or restricting nutrients, food, and/or fluids from entering the body within duodenum 115. or can be prevented (this procedure may include, but is not limited to, a gastrointestinal anastomosis procedure, a gastrojejunostomy procedure, and/or a gastroduodenal anastomosis procedure). This can limit and/or prevent certain medical conditions such as weight gain and diabetes. The medical professional may later remove the pylorus occlusion device 265 and/or the anastomotic stent 260, thereby increasing the absorption of food, fluids, and/or nutrients by the stomach 105 and/or duodenum 115. is understood. Although endoscopic procedures for placing anastomotic devices are described herein, additional procedures and device features for pyloric occlusion devices and anastomotic stents, stent placement, that may be useful are described in March 2019. U.S. Patent Application Publication No. 2019/0298401 entitled "System and Method for Performing Endoscopic Procedures," filed on October 22, 2019, and published on October 3, 2019; Found in the full disclosure of U.S. Patent Application Publication No. 2019/0298559, entitled "Devices, Systems, and Methods for Pyloric Obturation," filed on May 22, 2019, and published on October 3, 2019. be able to.

As mentioned above, the distal end 235 of the nasal catheter 230 may be placed in the jejunum 120 to assist the medical professional in determining the appropriate location for deploying the anastomotic stent. An exemplary positioning device for positioning the distal end of a nasal catheter is shown in FIG. 3A. For example, the distal end may include a positioning device 300 attached to a sheath, guidewire, or catheter 305 at its proximal end. As used herein, the term "elongated member" refers to any catheter (nasal catheter, oral catheter, anal catheter, or other endoscopic catheter), unless otherwise specified. ), sheath, shaft, guidewire, wire, endoscope, or any member attached thereto, including the positioning device 300 (with or without a lumen extending therethrough). May include. It will be appreciated that the positioning device 300 may be positioned proximal to the distal-most end of the sheath, guidewire, or elongate member 305, as shown in FIG. 3B. For example, elongate member 305 may be used to provide structural support for moving elongate member 305 proximally and/or distally, or when a medical professional places a guidewire within small intestine 125 and moves elongate member 305 proximally and/or distally. A guide wire or the like may be included to allow sliding along the guide wire. The positioning device 300 may be attached to the outer surface of the elongate member 305 using an adhesive or the like and may be located a distance from the distal-most end of the elongate member 305, for example at a distance of about 15 cm. Elongate member 305 can be, but is not limited to, a length of about 4 meters or less, such as about 3 meters. Elongate member 305 has a diameter of about 0.035 inches (about 0.0889 centimeters), or about 0.025 inches (about 0.0635 centimeters) for elongate members 305 without lumens. The elongate member 305, which includes a lumen, may have a diameter of about 7F (about 2.3 millimeters), or about 5F (about 1.7 millimeters). The distance and diameter are not limited and may vary depending on the size of the patient and/or the treatment procedure being performed by the medical personnel.

Elongate member 305 may also include a loop 312, as shown in FIG. 3B, where the distal end of elongate member 305 is bent or curved such that the most distal end of elongate member 305 It is oriented proximally. Loop 312 may be formed after introducing elongate member 305 into the body by pushing elongate member 305 distally. For example, at least a portion of elongate member 305 may be flexible or have variable stiffness, such that the distal end of elongate member 305 can be folded back on itself during a medical procedure. to form a loop 312 from the straight line configuration. As elongate member 305 is moved proximally, loops 312 can approach a straight configuration. Loop 312 may provide a blunted end, which may reduce the possibility of perforation of the intestine when manipulating elongate member 305 and increase the accuracy of positioning of positioning device 300. Alternatively, the loop 312 may be formed in or around the guidewire, and the elongate member 305 may extend along the guidewire through the lumen, as described herein. good. It will be appreciated that conductive wires for conducting electricity may be disposed within the lumen of elongated member 305 and/or disposed on the outer surface of elongated member 305. Alternatively, the conductive wires may be encapsulated within the walls of the elongate member 305 and/or between the walls of the elongate member 305 in multiple layers.

According to the example shown in FIG. 3A, positioning device 300 may include one or more light emitting diodes (LEDs) 310. Positioning device 300 may include a side wall 302, a distal end wall 304, and a proximal end wall 306. The positioning device 300 may be a capsule, for example, and may take any shape including, but not limited to, an ellipsoid, a cuboid, or a sphere. Sidewall 302 may be a single wall having a cylindrical shape, as shown in FIG. 3A, or sidewall 302 may include multiple sidewalls forming, for example, a rectangular prism. An interior space 308 may be formed between side wall 302, distal end wall 304, and proximal end wall 306. Space 308 may include fluid, atmosphere, and/or inert or other gas. For example, the positioning device 300 may include an alternative light emitting feature, where electrodes are provided within the interior space 308 and at opposite ends of the interior space 308, and a gas, such as neon gas, is disposed within the interior space 308.

According to one example, LED 310 may be disposed within interior space 308. Each of the LEDs 310 may have any shape, such as, but not limited to, a rectangle. Additionally or alternatively, some LEDs 310 may be triangular (e.g., three LEDs 310 angled at 120 degrees for each adjacent LED 310), cubic (e.g., for each adjacent LED 310 They may be arranged in any shape, including four LEDs 310 angled at 90 degrees, and/or an in-line orientation may be formed such that each LED 310 points in a different direction. Light emitted from the LED 310 may be emitted from the interior space 308 of the positioning device 300 through the sidewall 302, which may be transparent or translucent. According to one example, one or both of the distal end wall 304 or the proximal end wall 306 may include or be formed from an opaque or otherwise light attenuating material, thereby allowing the LED 310 to be Emitted light may be focused through sidewall 302 to assist medical professionals in positioning positioning device 300. As described in detail herein, each diode from LED 310 can emit one or more wavelengths of visible light, as described herein. The number of LEDs 310 is not limited. As an example, a single red LED 310 and a single green LED 310 may be on a first side of the elongate member 305, and a single red LED 310 and a single green LED 310 may be in a circle of the sheath or guidewire 305. They may be arranged on opposite sides in the circumferential direction. As another example, one or more red LEDs 310 may be on a first side of elongate member 305 and one or more green LEDs 310 may be on a circumferentially opposite side of elongate member 305. Good too. Alternatively, there may be one LED of each color or, for example, from two to ten or more LEDs 310 of each color. Alternatively or additionally, LED 310, and any LED described herein, may be arranged in multiple rows, such as two rows parallel or substantially parallel to the longitudinal axis of elongated member 305 and positioning device 300. They may be arranged in more than one row and may be arranged around the entire circumference of elongate member 305 or may extend around only a portion of the circumference of elongate member 305.

Alternatively, positioning device 300 may include one or more LEDs 310 disposed on elongated member 305, as shown in FIG. 3B. FIG. 3B shows one arrangement of two LEDs 310, the colors of each of these LEDs 310 may be the same or different, for example one green LED 310 and one red LED 310. good. As a further example, LEDs 310 may be arranged in an array of 1 to 20 LEDs, or 4 to 6 rows of LEDs, with each row parallel to the longitudinal axis of elongated member 305 and positioning device 300. The rows may be arranged circumferentially around elongated member 305. Alternatively, LED 310 may be placed on only one side of elongated member 305, for example to focus the light emitted from LED 310 on only one side of positioning device 300. The LED 310 may be blinked in a pattern, for example turned on and off. For example, LED 310 may be flashed at about 1 Hertz, with a duty cycle of about 10-15%, and a current of about 150 mA.

A coating, such as an electrically insulating heat shrink or a hardened material such as an adhesive, is placed over the side wall 302, distal end wall 304, and proximal end wall 306, or the coating covers all or a portion of the LED 310. may completely replace these walls. This coating is not limited to the location of the LED 310 alone, but may extend distally and/or proximally along the elongate member 305 to ensure sufficient adhesion of the LED 310 to the elongate member 305. The coating may be transparent or translucent so that light from LED 310 may be transmitted therethrough.

Each LED 310 can emit red and/or green light. Red light is absorbed relatively little by human tissue, so it is scattered, but it has high penetration into human tissue, so it is easier to see from a distance than green light. Green light is absorbed relatively more by human tissue, resulting in lower transmittance than red light. However, green light is more easily positioned than red light because it is less scattered within the body. Additionally, medical personnel's eyes and endoscope image sensors (e.g., CMOS image sensors, etc.) are generally more sensitive to green light wavelengths than red light wavelengths, which may be due to the specific Position determination can be further improved. For example, LED 310 (e.g., first LED 310) may be controlled to emit red light to determine the approximate area in which positioning device 300 is located, and LED 310 (e.g., second LED 310) may be controlled to emit red light to determine the approximate area in which positioning device 300 is located. ) may emit green light to more specifically identify the exact location of the positioning device 300. Therefore, the red light is a coarse locator or primary alignment to identify and orient the medical device to the desired location, and the green light is the coarse locator or primary alignment to identify and orient the medical device to the desired location. It may be a fine adjustment or a second adjustment. In some embodiments, the red light may be manually (or automatically) switched to green light when the user generally positions the medical device as desired. In some embodiments, the red and green lights may alternate at preselected intervals, allowing the user to view the medical device as the red and green lights alternate. It can be directed to the desired position. Additionally or alternatively, the LEDs 310 can simultaneously generate red and green light, e.g., a first LED 310/light array generates a red light and a second LED 310/light array generates a red light. Green light may also be generated. It will be appreciated that LED 310 is not limited to these colored lights and may include other lights, including but not limited to white light.

Referring to FIG. 3A, the distal end of the sheath, guidewire, or elongated member 305 may extend through an opening in the proximal end wall 306, and the opening is then sealed around the elongated member 305. Good too. Elongate member 305 is configured to transmit electrical energy to LEDs 310 from a power source (e.g., a generator, battery pack, or equivalent energy source) at the proximal end of elongate member 305 and to provide independent control for each LED 310. A plurality of wires, e.g. two positive electrode wires ( (one positive wire for the anode terminal of each LED 310) and a common cathode return terminal wire. For example, the wires may be included in a lumen or layer of the elongate member 305 that extends from the proximal end to the distal end of the elongate member 305, and/or the wires may be included along the outer surface of the elongate member 305 in the proximal It may extend from the end to the distal end. The wire is also insulated with a biocompatible polymer and may be left uncovered or attached to a member with higher rigidity. In this case, the wire may form a "pill-on-a-string" and be placed in the desired position via peristalsis.

According to another example, positioning device 300 may include a diffuser instead of LED 310. Elongated member 305 may include a plastic or glass diffused light pipe (elongated member 305 may be a diffused light pipe, or the light pipe may replace electrical wires that conduct electricity to LED 310 ). Elongated member 305 may include a reflective surface for advancing light to a distal end of elongated member 305. For example, light may be coupled at the proximal end of elongate member 305 using a light source. Once the light reaches the positioning device 300, the disperser can disperse the light from the positioning device 300 in one or more directions, thereby illuminating the positioning device 300. A medical professional can activate the light source in any of the ways described herein.

As shown in FIG. 3D, another example of a positioning device 300' on a guidewire, sheath, or elongate member 305' is shown. A positioning device 300' that includes one or more LEDs 310' may be positioned approximately 15 cm proximal to the distal tip 315' of the guidewire 300'. The distal tip 315' has a rounded or otherwise blunted end to minimize harm to the esophageal passageway during insertion. As described herein, wires for transmitting electricity from a power source to the LED 310' may be placed on or within the guidewire 300'. Elongated member 305' may have a diameter of about 0.035 inches (about 0.0889 centimeters), or about 0.025 inches (about 0.0635 centimeters). It will be appreciated that the positioning device 300' may be placed at any location along the elongated member 305'. It will also be appreciated that the guidewire 300' may be inserted into the patient's body and advanced into the small intestine 125 in any manner described herein.

As shown in FIG. 3C, the sheath, guidewire, or elongated member 305 includes markers, such as pyloric markers 305a, 305b, and 305c, to indicate the distance that the positioning device 300 has moved when inserted into a patient, and teeth. Markers 305a', 305b', and 305c' may also be included. For example, a first pylorus marker 305a may be placed on elongate member 305 approximately 155 cm proximal to positioning device 300, and a second pylorus marker 305b may be placed on elongate member 305 approximately 170 cm proximal to positioning device 300. The third pyloric marker 305c may be located approximately 185 cm proximal to the positioning device 300. Additionally or alternatively, a first tooth marker 305a' may be positioned on the elongated member 305 approximately 250 cm proximal to the positioning device 300, and a second tooth marker 305b' may be positioned on the elongate member 305 approximately 250 cm proximal to the positioning device 300. The third tooth marker 305c' may be positioned on the elongate member 305 approximately 265 cm proximal to the positioning device 300, and the third tooth marker 305c' may be positioned approximately 280 cm proximal to the positioning device 300. The markers may assist and/or indicate the approximate location of the positioning device 300 with respect to the patient's anatomy. For example, as described herein, the positioning device 300 may be used by a medical professional to determine that the positioning device 300 has been moved approximately 250 cm into the patient when the first tooth marker 305a' is aligned with the patient's teeth. As will be appreciated, it can be introduced via the mouth, the esophageal route, and/or another percutaneous gastrointestinal access point. Similarly, once the second tooth marker 305b' and the third tooth marker 305c' are aligned with the patient's teeth, the medical professional knows that the positioning device 300 has been moved approximately 265 cm and 280 cm into the patient, respectively. you will understand. However, in some cases, elongate member 305 may loop within stomach 105 and tooth markers 305a', 305b', and 305c' may not provide accurate distance results. Accordingly, a medical professional can use an image sensor at the distal end of endoscope 240 to determine the distance from positioning device 300 to small intestine 125 by pylorus markers 305a, 305b, and 305c. For example, when the first pylorus marker 305a is aligned with the pylorus 110, as determined using an image sensor, the medical professional determines that the positioning device 300 has extended approximately 155 cm from the pylorus 110 into the small intestine 125. can do. Similarly, when the second pylorus marker 305b and the third pylorus marker 305c are aligned with the pylorus 110, the medical professional determines that the positioning device 300 has been extended approximately 170 cm and 185 cm from the pylorus 110 into the small intestine 125, respectively. be able to.

Alternatively or additionally, the elongate member 305 has an outer surface of the elongate member 305 having a first color between the locating device 300 and the first pyloric marker 305a (or at a position approximately 155 cm from the locating device 300). , a second color on the outer surface between the first pylorus marker 305a and the second pylorus marker 305b (or at a position approximately 170 cm from the positioning device 300), and the second pylorus marker 305b and the third pylorus marker 305c. (or a position approximately 185 cm from the positioning device 300) and a third color on the outer surface between the third pyloric marker 305c and the first tooth marker 305a' (or a position approximately 250 cm from the positioning device 300). All position markers on the elongate member 305 may be color coded in a similar manner below, such as a fourth color on the outer surface. Non-adjacent areas, such as the area between the positioning device 300 and the first pylorus marker 305a and the area between the second pylorus marker 305b and the third pylorus marker 305c, may have the same color. That will be understood.

The placement of markers (and/or color transitions) is not limited to the positions described herein. For example, markers may be placed along elongate member 305 based on a patient's physical characteristics; for example, markers may be placed further along elongate member 305 for use with a taller patient than a smaller patient. They may be spaced apart and/or placed along the elongate member 305 based on the medical problem being treated, eg, a morbidly obese patient may be more likely to be placed than a patient with mild to moderate obesity. Positioning device 300 at a more distal location in jejunum 120 may also require markers spaced further apart along elongated member 305.

Pyloric markers 305a-305c and tooth markers 305a'-305c' may include any identifying elements, such as colored markings, raised areas on elongate member 305, decals, text identifying distance from positioning device 300, a series of circumferences, etc. It will be appreciated that a striped pattern in the direction or the like may also be used. Each of the pyloric markers 305a-305c and the tooth markers 305a'-305c' may include a plurality of markings, for example, the first pylorus marker 305a may include a plurality of same color-coded markers in the same area of the elongate member 305. good. As such, elongate member 305 may be suitable for use with patients of all sizes and/or with all medical procedures. Pyloric markers 305a-305c and tooth markers 305a'-305c' may also include characteristics identified by various medical imaging modalities. For example, the pyloric markers 305a-305c and/or the tooth markers 305a'-305c' may be radiopaque so that the position of each marker can be determined during a medical procedure using known medical imaging techniques. Good too. The elongate member 305 may have a strength suitable for pulling and/or pushing the elongate member 305, e.g., to move the elongate member 305 when the elongate member 305 is placed within a patient. A guidewire may be used to position the positioning device 300 within the body, and the guidewire and/or elongated member 305 may include these markers.

Next, a method for arranging and operating positioning device 300 will be described. Endoscopic procedures can be performed as discussed herein with reference to FIGS. 2A-2F. Prior to the procedure, positioning device 300 may be administered orally to the patient and swallowed. The proximal end of elongated member 305 may extend through the patient's nose. According to one example, the positioning device 300 may be advanced along the gastrointestinal tract via peristalsis. In such an example (positioning device 300 swallowed and moved via peristalsis), the positioning device 300 may be delivered through the nasal cavity several hours before the proposed procedure. Alternatively, for elongate members 305 with relatively high pushability, elongate members 305/positioning device 300 may be positioned endoscopically using an endoscope, such as endoscope 240.

Once the positioning device 300 is properly placed within the gastrointestinal tract to aid in proper placement, the proposed treatment can begin. For example, an imaging modality (e.g., an imaging device and/or a device for locating a radiopaque device) can be used to determine when the pylorus markers 305a-305c are properly placed in the pylorus. . Alternatively or additionally, treatment can begin when the tooth markers 305a'-305c' are properly placed in the patient's mouth/teeth. The proper location of these markers can indicate to a medical professional that the positioning device 300 is placed in the proper location within the jejunum 120. Alternatively, for elongated members 305 with higher pushability, the pylorus markers 305a-305c are placed in the pylorus and/or the tooth markers 305a'-305c' are Elongated member 305 can be pushed until it is placed in the mouth.

Elongated member 305 may be connected to a power source before, during, or after introducing positioning device 300 into a patient. LED 310 may be activated at any point during the procedure. Alternatively, LED 310 may be activated when positioning device 300 is advanced a certain distance into the patient, as indicated by one or more markers 305a-305c. The medical professional may create an incision in the wall of the stomach 105, such as in the antrum of the stomach 105, and advance the endoscope 240 through the incision. The medical professional may then visualize the abdominal cavity using a camera or other imaging device at the distal end 245 of the endoscope 240 to determine the position of the positioning device 300 within the jejunum 120. . For example, a medical professional viewing an image of the abdominal cavity, such as on a monitor associated with a camera of endoscope 240, may determine the position of positioning device 300 within jejunum 120 using light from LED 310 transmitted through the wall of jejunum 120. can be determined based on the location of Positioning device 300 can provide a medical professional with the appropriate location for creating a perforation or incision in the wall of jejunum 120 in steps 215 and 220 described herein. In this way, the anastomosis device can be properly placed. Alternatively, the medical professional can view the positioning device 300 through both the jejunum 120 wall and the stomach 105 wall, which allows the medical professional to make an incision in both the stomach 105 wall and the stomach 105 wall. It can help determine where to make the incision.

LEDs 310 may be activated according to a pattern. For example, one or more red LEDs 310 may be activated before or after positioning device 300 is orally administered, and may be illuminated continuously or pulsed. A medical professional can determine when the red light is positioned by a camera at the distal end 245 of endoscope 240. The medical professional may then deactivate the red light and activate the green light. It will be appreciated that the green light may be lit continuously or pulsed as well. Additionally, activation of the green light and deactivation of the red light may be performed automatically by a controller associated with the camera. After the green light is activated, the medical professional may further manipulate the distal end 245 of the endoscope 240 to place the end effector 250 in the proper position for creating an incision in the jejunum 120. can. Alternative embodiments include activating both the red and green lights at the beginning of the procedure, and/or pulsing one or both lights during the procedure, and/or the positioning device 300 being positioned by a camera. may include deactivating the red light when the red light is activated. One or more white lights may also be activated throughout the procedure, allowing the medical professional to better position the positioning device 300 once an incision is made in one or more of the stomach 105 and jejunum 120. It can be helpful for good positioning.

Another example nasal catheter 430 (which may include any catheter, sheath, or wire described herein) is shown in FIGS. 4A and 4B. According to one example, nasal catheter 430 may include a lumen 440 extending from a proximal end and may include a positioning device, such as positioning device 300, attached to its distal end. For example, outer sheath/tube 431 of nasal catheter 430 can define lumen 440. Lumen 440 may include elongated member 305 as described in connection with FIGS. 3A-3C. However, sheath 431 may include markers for determining distance. Outer sheath 431 may include a material that is sufficiently rigid to be manipulated, e.g., pushed or pulled, within the patient's body without relying on bodily functions such as peristalsis to direct nasal catheter 430 to a target within jejunum 120. can be moved to position. Outer sheath 431 may include a hole 432 that allows fluid connection between lumen 440 and the interior of the gastrointestinal pathway when nasal catheter 430 is inserted into a patient's body. Alternatively, holes 432 may be formed directly in the wall of elongate member 305 to allow fluid to pass within the central lumen of elongate member 305 (e.g., fluid may pass through adjacent coated electrical wires). ). Holes 432 may be provided only at the distal end of sheath 431 and/or holes 432 may also be located along the middle and/or proximal length of nasal catheter 430. Holes 432 may be located along substantially the same circumferential side of sheath 431 and/or may be located around the circumference of sheath 431 at multiple locations along the length of sheath 431. good. The diameter of the hole is approximately 0.020 inch to 0.040 inch (approximately 0.0508 cm to 0.1016 cm), or approximately 0.025 inch to 0.030 inch (approximately 0.0635 cm to 0 .0762 centimeters). The holes 432 may assist in venting the gastrointestinal tract, such as the stomach 105 and/or the small intestine 125, thereby allowing the release of insufflated and/or naturally occurring gases from the gastrointestinal tract. These gases can cause the walls of the stomach 105 and/or the small intestine 125 (including the jejunum 120) to expand, causing the light from the LED 310 to have to travel from the positioning device 300 to the side walls of the jejunum 120. The distance may be increased to reduce the amount of light that passes from the jejunum 120 into the abdominal cavity and thus becomes visible by the endoscopic camera. This increased distance can make it difficult to locate positioning device 300 within jejunum 120 from the abdominal cavity. Hole 432 allows gases introduced into and/or generated from stomach 105 and/or small intestine 125 to be evacuated, thereby reducing dilation of the gastrointestinal wall and positioning device placed within jejunum 120. Visualization of light within the abdominal cavity and/or stomach 105 from 300 can be improved. A vacuum device can be attached to the proximal end of lumen 440 to actively remove gas, and/or a containment device can be attached to the proximal end of the lumen to contain gas removed from the gastrointestinal pathway. It will be understood that it is possible.

Next, a method for positioning and manipulating nasal catheter 430 will be described. Nasal catheter 430 can be introduced into the body in any of the ways described herein. For example, nasal catheter 430 may be introduced through the mouth or nose and advanced into the small intestine by manipulating and/or pushing the proximal end of nasal catheter 430 or via peristalsis. As nasal catheter 430 is moved along the gastrointestinal pathway, gas may actively or passively enter hole 432 and travel proximally along lumen 440 to reach the proximal outlet. good. For example, a vacuum or other pump may be connected to lumen 440 at the proximal end of nasal catheter 430, and the vacuum may actively draw gas from the gastrointestinal route. Alternatively, these gases may be passively moved along the proximal outlet of lumen 440. For example, gas buildup in the gastrointestinal tract can cause a pressure increase greater than atmospheric pressure. Due to the pressure differential between the gastrointestinal tract and the atmosphere surrounding the outside of the patient's body, these gases may flow along lumen 440 into hole 432 and exit through the proximal opening of lumen 440. can. It will be appreciated that a containment device may be attached to the proximal opening of lumen 440 to prevent gases from the body from being released into the treatment room. It will also be appreciated that gas may be continuously removed during the anastomosis procedure.

According to another example, as shown in FIG. 5, a positioning device 500 is attached to a catheter or sheath 502 (sheath 502 may include any catheter or nasal catheter described herein). Good too. Sheath 502 may include a guidewire lumen 504 through which a guidewire 505 may extend, allowing sheath 502 to move along guidewire 505. Positioning device 500 may be located at the distal end of sheath 502. For example, positioning device 500 may be disposed on the outer surface of sheath 502, may protrude from the outer surface of sheath 502, as shown in FIG. 5, and/or may be attached to a separate tube attached to sheath 502. may be provided. Alternatively, positioning device 500 may include a capsule, such as positioning device 300, disposed at the distal end of a sheath 502, with guidewire 505 extending through a central lumen of the capsule and extending through the sheath. 502 may be allowed to slide along guidewire 505. According to one example, positioning device 500 may be removably attached to sheath 502. In this way, different positioning devices 500, e.g. positioning devices 500 including different numbers of LEDs 510 and/or different colors of LEDs 510, may be exchanged according to the procedure being performed and/or the size or anatomy of the patient. . The increased stiffness of the sheath 502 and its trackability over the guidewire 505 can improve movement and maneuverability of the positioning device 500, thereby improving medical procedures. Alternatively, the positioning device 500 may be pulled into the small intestine 125 along the outer surface of the endoscope or through the lumen of the endoscope by an end effector, such as a pair of forceps.

Next, a method of introducing the positioning device 500 will be explained. Guidewire 505 may be introduced through a natural orifice, such as the mouth, and advanced along the gastrointestinal system. Sheath 502 is then inserted through the natural opening by placing sheath 502 around guidewire 505 through guidewire lumen 504. Sheath 502 may be advanced along the gastrointestinal system in any manner described herein. Additionally, LED 510 can be activated in any manner described herein.

According to another example, the positioning device 600 may be attached to the distal end of a sheath 602 (which may include any catheter or nasal catheter described herein) having a central lumen 604. good. Sheath 602 may be shorter than other catheters described herein and sized to support LED 610, as shown in FIG. For example, sheath 602 may only have a length sufficient to support LED 610, and may be about 20 cm, about 10 cm, or about 5 cm long. Push member 606 can be attached to the proximal end of sheath 602 to move sheath 602 along guidewire 605. The reduced size of the sheath 602 improves the maneuverability of the sheath 602, push member 606, and guidewire 605, thereby allowing the positioning device 600 to navigate tortuous paths within the patient and/or to navigate the gastrointestinal tract. Allows to navigate blockages or strictures within. Additionally, this may allow for rapid exchange of positioning device 600 from guidewire 605, which may allow a single medical professional to operate guidewire 605 and positioning device 600. . Push member 606 may be a wire suitable for use in medical procedures and may include any material sufficient for such use. Push member 606 may have a suitable rigidity to receive and move positioning device 600 along guidewire 605. It will be appreciated that electrical wires may be supported by the push member 606 so that the LED 610 can receive power.

Positioning device 600 may be deployed in any manner described herein. For example, guidewire 605 can be introduced as described for guidewire 605. Sheath 602 may then be placed over guidewire 605 via guidewire lumen 604. Push member 606 can then advance sheath 602 along guidewire 605 (via a force applied to the proximal end of push member 606). LED 610 may be activated in any manner described herein to allow a medical professional to position positioning device 600 using an endoscopic camera placed in stomach 105.

According to another example, the positioning device 700 can be attached to and/or surround the distal end of a sheath 702 (the sheath may include any catheter or nasal catheter described herein). good). Positioning device 700 may include an expandable balloon 704 that may surround LED 710, as shown in FIG. Balloon 704 includes a transparent or translucent material (e.g., polyethylene terephthalate (PET), polyethylene, polyamide copolymer (PEBA) latex, etc.) such that light from LED 710 can be transmitted through balloon 704 and into the wall of jejunum 120. But that's fine. LEDs 710 may be of any number and/or color and may be arranged on sheath 702 in any manner described in any of the embodiments herein. Sheath 702 has a central lumen 706 that can receive a guidewire 705 and allow sheath 702 to slide proximally and distally over guidewire 705 as described herein. May include. A fluid lumen 708 (shown in solid line) may extend through sheath 702 from the proximal end of sheath 702 to outlet 712 in fluid communication with the interior of balloon 704. Lumen 708 may allow fluid to be communicated therethrough to inflate balloon 704. For example, a fluid containment device may be attached to the proximal end of fluid lumen 708 and fluid may be introduced into or removed from balloon 704 through fluid lumen 708.

Next, a method for deploying the positioning device 700 will be described. Positioning device 700, including balloon 704, can be advanced to a target location according to any of the methods described herein. Balloon 704 is then inflated. Inflation of balloon 704 may cause balloon 704 to contact the wall of jejunum 120, thereby fixing the position of balloon 704 within jejunum 120. The contact between the balloon 704 and the wall of the jejunum 120 may eliminate any air and/or fluid gap between the positioning device 700 and the wall of the jejunum 120, which may lead from the LED 710 to the wall of the jejunum 120. Transmission of light through the and/or walls of the jejunum 120 can be increased to improve visualization of the positioning device 700. The LEDs 710 may include different colored light as described herein, such as red and/or green light, and the different colored light can be arranged in various patterns in any manner described herein. It is understood that it can be activated by Once positioning device 700 is placed by a medical professional and an incision is made in the wall of jejunum 120, balloon 704 may be deflated and sheath 702 removed from the body.

8A and 8B show another example of a positioning device 800. The positioning device 800 may include a balloon 804 on a first side of the distal end of a sheath 802 (sheath 802 may include any catheter or nasal catheter described herein) and a sheath from the balloon 804. An LED 810 may be included on the circumferentially opposite side of 802 . Balloon 804 may extend around only a portion of the circumference of sheath 802. The position of the LED 810 is not limited thereto, and may extend around the circumference of the sheath 802 to enhance visibility of the positioning device 800. Sheath 802 may include a central lumen 806 and may be advanced over guidewire 805 (within lumen 806) to position positioning device 800 adjacent the wall of jejunum 120. Balloon 804 may be inflated using a fluid lumen 808 (shown in solid line), such as fluid lumen 708 of sheath 702, as shown in FIG. 8B. For example, fluid lumen 808 may be connected at a proximal end to a fluid containment device for introducing or removing inflation fluid. Inflating the balloon 804 may cause the side of the balloon 804 opposite the sheath 802 to contact the entirety of the jejunum 120 and force the distal end of the sheath 802 against the opposing wall of the jejunum 120. This expansion may force or force the LED 810 against the wall of the jejunum 120 to eliminate any air and/or fluid gap between the positioning device 800 and the wall of the jejunum 120. This, in turn, may increase the transmission of light from the LED 810 to and/or through the wall of the jejunum 120 and improve visualization of the positioning device 800 by an imaging device within the stomach 105. can. Positioning device 800 can be deployed similarly to positioning device 700.

Another example of a positioning device 900 is shown in FIG. Similar to positioning devices 700 and 800, positioning device 900 may include a balloon 904 at the distal end of a sheath 902 (the sheath may include any of the catheters or nasal catheters described herein), and the jejunum. 120 may be expanded to position the LED 910 against the wall 120. Balloon 904 may entirely surround the distal end of sheath 902. Similar to positioning devices 700 and 800, sheath 902 may include a central lumen 906. The configuration of sheath 902 may allow sheath 902 to be advanced along guidewire 905 (disposed within lumen 906) to a target site within jejunum 120. Once the positioning device 900 is placed at the target site, the balloon 904 is moved in any manner described herein, such as using a fluid lumen 908 attached at its proximal end to a containment device containing inflation fluid. May be expanded. LED 910 may be placed on the outer surface of balloon 904. Wires (not shown) that provide current/power to the LED 910 may extend through the sheath 902 into the interior of the balloon 904 or along the surface of the balloon 904 and be electrically connected to the LED 910. . Inflation of balloon 904 can force or bias LED 910 against the wall of jejunum 120. The LEDs 910 may be arranged around the balloon 904 alternating with red and green lights, or the LEDs 910 may be arranged around the balloon 904 adjacent to an array of green lights similarly arranged around the balloon 904. may include an array of red lights arranged circumferentially. LEDs 910 may be centrally located along the longitudinal axis of balloon 904 or equally spaced around the circumference of balloon 904. Alternatively, LED 910 may be placed on the outer surface of balloon 904 circumferentially opposite balloon 904, which may improve visualization of LED 910. It will be appreciated that the red and green lights of LED 910 may be activated independently or together in any manner described herein.

Another example of a positioning device 1000 is shown in FIGS. 10A and 10B. Similar to the positioning devices described herein, the positioning device 1000 may be disposed at the distal end of a sheath 1002 (the sheath may include any catheter or nasal catheter described herein). . Sheath 1002 may include a central lumen 1006 through which a guidewire 1005 may extend. Sheath 1002 may include a distal tip 1002a connected to sheath body 1002b by a plurality of wires 1002c. Distal tip 1002a may be ring-shaped and include a lumen for tracking over guidewire 1005, which may be an extension of central lumen 1006 from sheath body 1002b. The distal tip 1002a may have the same or different outer circumference than the sheath body 1002b. LED 1010 may be placed on each of the plurality of wires 1002c. For example, each of the plurality of wires 1002c may include a green LED 1010 and a red LED 1010, or may include a plurality of green and red LEDs 1010. Alternatively, each of the plurality of wires 1002c may include only one LED 1010, and the color of the LEDs 1010 may alternate around the circumference of the sheath 1002. Alternatively, each LED 1010 may connect the proximal end of each wire 1002c to its respective distal end. Wire 1002c can provide current/power to LED 1010. Tension wire 1003 may be attached to distal tip 1002a and extend therefrom to the proximal end of sheath 1002. Wire 1003 may be translated within lumen 1006 and actuated to move distal tip 1002a proximally and distally. For example, as tension wire 1003 is moved proximally, distal tip 1002a is also moved proximally, bending wires 1002c radially outward from guidewire 1005. In this manner, the LEDs 1010 disposed on the plurality of wires 1002c may be moved toward and pressed against the walls of the jejunum 120.

Next, a method for deploying the positioning device 1000 will be described. It will be appreciated that the positioning device 1000 may be advanced to a target location in any manner described herein. Once the positioning device 1000 is placed within the jejunum 120, the medical professional may control the tension wire 1003 to move the distal tip 1002a proximally while maintaining the fixed position of the body 1002b ( For example, wire 1003 may be pulled proximally). This movement moves the LED 1010 away from the longitudinal axis of the sheath 1002, forcing or biasing the LED 1010 against the wall of the jejunum 120. Next, positioning device 1000 may be placed and incisions created in the walls of stomach 105 and jejunum 120 in any manner described herein. After the incision is formed, the medical professional controls tension wire 1003 (e.g., pushes wire 1003 distally) to move distal tip 1002a distally while maintaining a fixed position of body 1002b. , the LED 1010 may be moved radially inward to approximate the guidewire 1005. It will be appreciated that it is possible to maintain the position of the distal tip 1002a while moving the body 1002b in the proximal and/or distal direction. Once LED 1010 is no longer deployed, sheath 1002 may be removed from the patient.

In various procedures, medical professionals may have difficulty locating a portion of a body lumen that includes a medical device locator. 11A-11C illustrate a portion of a gastrojejunostomy procedure that is substantially similar to the procedure of FIGS. 2B-2D. For example, in FIGS. 2C and 2D, the portion of the jejunum 120 that includes the distal end 235 of the nasal catheter 230 is extended through the wall of the stomach 105 with the distal end 245 of the endoscope 240 to visualize the small intestine 125. After that, it may be difficult to pinpoint the location. Similar difficulties in other procedures are contemplated in connection with locating devices and/or anatomical structures. 11A-11C illustrate a portion of a procedure for placing a medical device locator at a target location within the jejunum. The medical device locator at the target location can be visualized by an instrument insertable through the stomach wall. Once visualized, the target location within the jejunum can be accessed with instruments and a stent or other drainage conduit can be placed to bridge the stomach and jejunum.

Referring to FIG. 11A, a sheath, guidewire, or elongate member 1100 is shown inserted into the gastrointestinal tract through the stomach 1134 and extended into the duodenum 1136 and jejunum 1130. Endoscope 1124 is shown extended into stomach 1134 with a piercing or cutting mechanism 1120 extending distally from the working channel of endoscope 1124 toward the tissue wall of stomach 1134. The piercing mechanism 1120 makes an incision through the wall of the stomach 1134 into the abdominal cavity 1138 and generally towards a portion 1132 of the jejunum 1130 that includes the positioning device 1102 at the distal end of the elongated member 1100 extending into the jejunum 1130. It has been shown that

Referring to FIG. 11B, the endoscope 1124 of the system of FIG. 11A is shown extended into the abdominal cavity 1138 through an incision in the tissue wall of the stomach 1134. Endoscope 1124 is generally directed at jejunum 1130 within abdominal cavity 1138. A medical professional may visualize jejunum 1130 within abdominal cavity 1138 via endoscope 1124 and/or via other viewing techniques, such as fluoroscopy. The medical professional observes the jejunum 1130 and uses any visual indicator described herein, such as an illuminated LED, to determine the position of the jejunum 1130 in relation to the position of the elongate member 1100 and/or the positioning device 1102 contained therein. Portion 1132 can be identified. An end effector 1122, such as a grasper, holds the portion 1132 of the jejunum 1130 in place so that the portion 1132 of the jejunum 1130 can be manipulated for dissection and/or against the stomach 1134. Shown as grasping. In FIG. 11B, portion 1132 has been manipulated closer toward stomach 1134 compared to the position in FIG. 11A.

Referring to FIG. 11C, a portion 1132 of jejunum 1130 is shown manipulated into a position toward stomach 1134 from FIGS. 11A and 11B. A piercing mechanism 1122 is shown making an incision in a portion 1132 of the jejunum 1130, and the positioning device 1102 is positioned proximally from the portion 1132 to avoid collision with and/or heat transfer from the piercing mechanism 1122. It has been translated in parallel. However, positioning device 1102 may be left in portion 1132 for treatment. Additional devices may be delivered to the tissue wall of the stomach 1134, the tissue wall of the jejunum 1130, and/or as described herein by making incisions in the tissue wall of the stomach 1134 and the tissue wall of the portion 1132 of the jejunum 1130. It may extend into the abdominal cavity 1138 as described.

In various embodiments, the elongated member may be a sheath that extends around a catheter (eg, a nasal catheter, etc.), an endoscope, a guidewire, or another medical device. The elongate member may have a visual indicator along its length, and the length may extend distally to a positioning device, as described herein.

Referring to FIG. 12, an embodiment of a medical device locator includes a sheath, guidewire, or elongated member 1200 having a proximal end 1200p, a distal end 1200d, and a length extending along a longitudinal axis L therethrough. It is shown. LEDs 1204 are positioned along the length of elongated member 1200. LEDs 1204 are arranged helically about longitudinal axis L of elongated member 1200. Positioning device 1202 is located at distal end 1200d of elongated member 1200.

In various embodiments, the lighting member, which may be an LED, may extend along a portion of the length of the elongate member. The LED may extend to the distal end of the elongated member that includes the positioning device. The LEDs may be arranged, for example, helically, axially, radially, circumferentially, linearly, intermittently spaced, randomly, with varying density along the length, or in an arrangement thereof. The LEDs may be arranged in various patterns along the elongate member such that the LEDs are visible from one or more of the radial viewing angles from the longitudinal axis of the elongate member, such as in combination. The LED may be activated to emit light. The activated LED may be visible across the tissue wall, for example from outside the body lumen containing the LED. The LED may have a variable wavelength so as to emit as an indicator a color that is more easily visible across the tissue wall than other colors, such as red, green, etc. LEDs may be operated at various frequencies as indicators. The indicator may specify a location, eg, the indicator may be at a particular distance from the end of the elongated member, positioning device, or anatomical structure. The LEDs may be individually selectable and controllable as a single LED or as a group of multiple LEDs. LEDs may vary depending on density, location of the LEDs relative to each other, anatomical structure or medical device, size, shape, frequency of activation (e.g., patterning to aid in localization or notification, such as a double blink followed by a pause) , intensity of actuation (e.g., use of a current source with pulse width modulation (PWM) operating at a desired frequency and/or duty cycle to influence the intensity of the LED), duration of actuation, color, or any of the foregoing. It may be controllable by one or more parameters, such as any combination of two or more of them.

In various embodiments, a controller may be electrically coupled to the LED along the elongate member. Electrical leads may be interleaved in electrical communication with the LEDs so that the LEDs can be operated independently. The controller may be configured to sequentially activate one or more LEDs at a time. The controller may sequentially activate the LEDs in a distal direction along the length of the elongate member, for example, to indicate a direction toward the distal end of the elongate member toward the positioning device. The controller is configured to sequentially activate the LEDs such that a single LED or multiple LEDs are activated at a time, such as in an activation pattern of illumination waves traveling distally along the elongated member. Good too. The controller may be configured to operate all but one LED in a distally continuous pattern such that a large number of the LEDs (e.g., 90% or more of all LEDs, etc.) e.g. It is actuated for locating while indicating the direction of the actuation pattern of the extinguishing wave traveling distally along the elongated member. The controller is shorter to reduce heat compared to LEDs that are operated at a lower frequency (e.g., at a higher duty cycle, where the percentage of time the LED is lit is higher) with longer illumination times. The LED may be configured to operate at a higher frequency during illumination time (eg, at a lower duty cycle where the LED is illuminated for a lower percentage of the time). The controller may be configured to operate a portion of the LED at a first frequency and another portion of the LED at a second frequency, e.g. It may also be operated at a higher frequency than the other parts. The LED may extend along the length of the elongated member for a distance substantially along the patient's anatomy. For example, the LED may extend along the length between the pylorus and the target location for treatment of a portion of the jejunum. This may be any desired length, such as about 50 centimeters distal to the pylorus, about 150 centimeters distal to the pylorus, etc. The controller can be operated manually or automatically to activate one or more LEDs or to switch between various operating patterns. Such operation of the LED may be shortened to reduce heat.

Referring to FIG. 13, an embodiment of a medical device locator includes a sheath, guidewire, or elongated member 1300 having a proximal end 1300p, a distal end 1300d, and a length extending along a longitudinal axis L therethrough. It is shown. LEDs 1304 are positioned along the length of elongated member 1300. The LEDs 1304 are arranged linearly about and along the longitudinal axis L of the elongate member 1300. Positioning device 1302 is located at distal end 1300d of elongate member 1300. The LED is configured to emit variable wavelengths. A proximal portion 1305 of the LED 1304 is configured to emit light at a red wavelength, a central portion 1306 of the LED 1304 is configured to emit light at a white wavelength, and a distal portion 1307 of the LED 1304 is configured to emit light at a green wavelength. configured to emit light. Portions 1305, 1306, 1307 indicate locations along elongated member 1300. Proximal portion 1305 shows a position along elongate member 1300 proximal to central portion 1306, which shows a position along elongate member 1300 proximal to distal portion 1307, which , showing the distal end 1300d or position along the proximal elongate member 1300 of the positioning device 1302. Portions 1305, 1306, 1307 may each be positioned at varying distances from distal end 1300d of elongated member 1300, such as proximal portion 1305 being positioned, such as about 50 centimeters from distal end 1300d. The central portion 1306 may be located at a location such as about 15 centimeters from the distal end 1300d, and the distal portion 1307 may be located at a location substantially at the distal end 1300d. good. Although three portions 1305, 1306, 1307 and three colors of LED 1304 are shown, any number and/or location of these portions and/or colors may be employed.

Referring to FIG. 14, an embodiment of a medical device locator is shown that includes a sheath, a guidewire, or an elongated member 1400 that may be, for example, a guidewire. Elongate member 1400 includes LEDs 1410, 1412 arranged along its length. Support member 1402 extends longitudinally within elongate member 1400. Board 1404 is positioned along support member 1402 such that board 1404 extends radially away from support member 1402. LEDs 1410, 1412 are arranged on opposite sides of board 1404 such that a first pair of LEDs 1410 is arranged on a first side of board 1404 and a second pair of LEDs 1412 is arranged on a second side of board 1404. be done. The LEDs 1410, 1412 are arranged on opposite sides of the board 1404 such that at least one pair of LEDs 1410, 1412 are visible as a 180° arc 1418 around the elongate member 1400. Each pair of LEDs 1410, 1412 may include variable color LEDs, e.g., green and red, to enhance visibility (e.g., across tissue) and/or to indicate direction (e.g., green (representing the distal direction of the elongate member 1400 and red indicating the proximal direction of the elongate member 1400) may both be illuminated, selectively illuminated, alternately illuminated, or sequentially illuminated. Although the pairs of LEDs 1410, 1412 are shown as a total of four LEDs 1410, 1412, the LEDs may be grouped into sections larger than the pairs, or not at all, and may be grouped in any number, e.g. , 2, 3, 5, 6, 8, 10, 15, 20, 50, 100, etc. LEDs may be employed. The LEDs 1410, 1412 may be illuminated and controlled by a wire conduit 1416 that is electrically coupled to the LEDs 1410, 1412 and extends within and proximally along the elongated member 1400. Wire 1416 may extend proximally along elongate member 1400 to connector 1420. Connector 1420 may be reversibly coupled to the controller and may be sized to fit into the working channel of the endoscope. The controller may include power supplies, circuits, instructions, and/or switches for powering and controlling lights, such as LEDs 1410, 1412, for example. Connector 1420 includes contacts 1422 in electrical communication with wire 1416, and contacts 1422 may be reversibly coupled to leads of the controller. The portions of the wires 1416 and LEDs that are externally exposed from the elongated member 1400 are exposed to the LEDs 1410, 1412, the board 1404, the wires 1416, and external fluids/debris (e.g., body fluids) while allowing visibility of the illuminated LEDs 1410, 1412. , and a transparent/semi-transparent coating 1424 (eg, silicone, etc.) that protects the electrical connection between it and the damage.

In use, an endoscope having a working channel may be inserted into a patient's duodenum, and elongated member 1400 may be extended through the working channel and into the duodenum. The elongate member 1400 may be further advanced along the small intestine to a desired location that can be observed and measured by markings (e.g., radiopaque and/or colored markings) on the elongate member 1400, and the elongate member 1400 and/or LEDs 1410, 1412 can indicate a desired distance beyond the pylorus (eg, about 150 cm). The endoscope can then be withdrawn proximally along elongate member 1400, leaving elongate member 1400 in the small intestine. When the distal end of the endoscope is withdrawn into the pylorus, elongate member 1400 may be adjusted proximally or distally, eg, to place markings of elongate member 1400 in the pylorus. The endoscope may then be completely withdrawn from the patient along elongate member 1400 and connector 1420. Connector 1420 may then be coupled to a controller that enables operation of LEDs 1410, 1412.

In general, as applicable to any of the locator devices and systems described above or included in this disclosure, embodiments of methods for positioning a medical device across a body lumen may be as described in the previous paragraph. The steps for positioning the locator device of FIG. 14 may include extending an elongate member including a plurality of LEDs along the length of the elongate member within a first body lumen, e.g., the jejunum. . The plurality of LEDs may be activated sequentially in a distal direction along the length of the elongate member. The sequentially activated LEDs may indicate the orientation of a device or anatomical structure, such as a positioning device and/or a portion of a first body lumen. The activated LED is visible across the tissue wall of the first body lumen, for example from within the abdominal cavity. A perforating mechanism, e.g. a cutting tool, is extended across a tissue wall of a second body lumen, e.g. a stomach, toward the first body lumen to make a cut against the tissue wall of the first body lumen. You may go.

It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of the disclosure. For example, the configuration of the positioning device and catheter can be modified to suit any medical device or procedure. It will be appreciated that the number and/or location of LEDs is not limited to the examples described herein. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims (18)

A medical device comprising an elongate member, the elongate member including a positioning device at a distal end of the elongate member, the positioning device including at least one light emitting diode (LED), the positioning device including at least one light emitting diode (LED), and the positioning device including at least one light emitting diode (LED). is configured to operate to emit light having wavelengths corresponding to green light and red light ;
The elongate member includes a fluid lumen extending from a proximal end of the elongate member to a distal end of the elongate member, a plurality of holes being disposed in a sidewall of the elongate member and fluidly connected to the fluid lumen. is,
The medical device further comprises a vacuum device and a fluid containment device, each of the vacuum device and the fluid containment device being in fluid communication with the fluid lumen at the proximal end of the elongate member, and the vacuum device , configured to create suction within the fluid lumen such that fluid from the body is configured to flow through the plurality of holes and along the fluid lumen to the fluid containing device; medical equipment. A medical device comprising an elongate member, the elongate member including a positioning device at a distal end of the elongate member, the positioning device including at least one light emitting diode (LED), and the positioning device including at least one light emitting diode (LED); is configured to operate to emit light having wavelengths corresponding to green light and red light;
The positioning device further includes a balloon at the distal end of the elongated member, the balloon being configured to be inflated;
The medical device wherein the balloon is disposed on a first side of the elongate member and the at least one LED is disposed on a circumferentially opposite side of the elongate member from the balloon. A medical device comprising an elongate member, the elongate member including a positioning device at a distal end of the elongate member, the positioning device including at least one light emitting diode (LED), and the positioning device including at least one light emitting diode (LED); is configured to operate to emit light having wavelengths corresponding to green light and red light;
The positioning device further includes a balloon at the distal end of the elongated member, the balloon being configured to be inflated;
The medical device, wherein the at least one LED includes a plurality of LEDs arranged around the balloon. A medical device comprising an elongate member, the elongate member including a positioning device at a distal end of the elongate member, the positioning device including at least one light emitting diode (LED), and the positioning device including at least one light emitting diode (LED); is configured to operate to emit light having wavelengths corresponding to green light and red light;
The medical device, wherein the at least one LED is configured to alternately emit green and red light. The medical device according to any one of claims 1 to 4 , wherein the positioning device comprises:
side wall;
a proximal end wall at the proximal end of the side wall;
a distal end wall at a distal end of the side wall, the side wall, the proximal end wall, and the distal end wall defining a cavity, and the at least one LED is disposed within the cavity. medical equipment. 6. The medical device of claim 5 , wherein the sidewall comprises a transparent or translucent material, and at least one of the proximal end wall or the distal end wall comprises an opaque or light attenuating material. A medical device, including one or more of: 5. The medical device of any one of claims 2-4 , wherein the elongate member includes a fluid lumen extending from a proximal end of the elongate member to a distal end of the elongate member, and wherein the elongate member includes a plurality of holes. is disposed on a sidewall of the elongated member and fluidly connected to the fluid lumen. 8. The medical device of claim 7 , wherein the medical device further comprises a vacuum device and a fluid containment device, the vacuum device and the fluid containment device each connecting the fluid conduit at the proximal end of the elongated member. in fluid communication with the fluid lumen, the vacuum device configured to allow fluid from the body to flow through the plurality of holes and along the fluid lumen to the fluid containing device. A medical device configured to generate suction within the medical device. 9. The medical device of any one of claims 1-8 , wherein the elongate member further includes a central lumen configured to receive a guidewire. 5. The medical device of claim 1 or 4 , wherein the positioning device further includes a balloon at the distal end of the elongated member, the balloon being configured to be inflated. 11. The medical device of claim 10 , wherein the balloon comprises a transparent or translucent material, the at least one LED is disposed on a surface of the elongate member, and the light emitted from the LED is A medical device configured to pass through the balloon. 11. The medical device of claim 10 , wherein the balloon is disposed on a first side of the elongate member and the at least one LED is disposed on a circumferentially opposite side of the elongate member from the balloon. medical equipment. 11. The medical device of claim 10 , wherein the at least one LED includes a plurality of LEDs arranged around the balloon. 5. The medical device of any one of claims 1-4 , wherein the elongate member includes a body of the elongate member and a distal tip of the elongate member, the distal tip of the elongate member being proximal to the distal tip of the elongate member. The medical device has an end connected to a distal end of the body of the elongated member by a plurality of wires, and one LED of the at least one LED is attached to each wire from the plurality of wires. 15. The medical device of claim 14 , further comprising an actuation wire attached to a distal tip of the elongate member, the actuation wire proximal to the body of the elongate member. configured to move, and the LED is configured to be moved radially outward as the actuation wire moves the distal end of the elongate member proximally relative to the body of the elongate member. medical equipment. Medical device according to any one of claims 1 to 3 , wherein the at least one LED is configured to alternately emit green and red light. Medical device according to any one of claims 1 to 16 , wherein the at least one LED is configured to emit green and red light in a pulsed manner. 18. The medical device according to any one of claims 1 to 17 , wherein the medical device is an endoscope, the medical device comprising: an imaging device; and an imaging device configured to extend from a distal end of the endoscope. an end effector, the imaging device configured to detect light having wavelengths corresponding to green light and red light emitted from the at least one LED. Device.

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